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About This Item

 

Full Description

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.

This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

Cross References:
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
EN 60601-1:2006/corrigendum Mar. 2010
ISO 14117:2019
ISO 14708-2:2019
EN 60601-1:2006
EN 60601-1:2006/A12:2014
IEC 60601-1-2:2014
IEC 60601-2-4:2010/AMD1:2018
IEC 60601-2-4:2010
IEC 61000-4-2:2008
EN 60086-1:2015
EN 60086-2:2016
IEC 60086-2:2015
EN 61000-4-2:2009
ISO 14708-1:2014
IEC 60086-1:2015
EN 60601-2-4:2011


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN IEC 60601-2-31:2020

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    Medical electrical equipment-Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

    • Most Recent
  2. BS EN 60601-2-31:2008+A1:2011


    Medical electrical equipment-Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

    • Historical Version
  3. BS EN 60601-2-31:2008


    Medical electrical equipment. Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

    • Historical Version
  4. BS 07/30165025 DC


    BS EN 60601-2-31. Medical electrical equipment. Part 2-31. Particular requirements for basic safety and essential performance of external cardiac pacemakers with internal power source

    • Historical Version
  5. BS EN 60601-2-31:1995


    Medical electrical equipment. Particular requirements for safety-Specification for external cardiac pacemakers with internal power source

    • Historical Version